NDC 45865-364

Diclofenac Sodium Extended-Release

Diclofenac Sodium

Diclofenac Sodium Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Diclofenac Sodium.

Product ID45865-364_f4dc2502-bb11-4c1d-a67d-67ea7785749c
NDC45865-364
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium Extended-Release
Generic NameDiclofenac Sodium
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA075910
Labeler NameMedsource Pharmaceuticals
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength100 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 45865-364-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-364-30)
Marketing Start Date2009-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-364-60 [45865036460]

Diclofenac Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05
Inactivation Date2019-11-13

NDC 45865-364-49 [45865036449]

Diclofenac Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05
Inactivation Date2019-11-13

NDC 45865-364-30 [45865036430]

Diclofenac Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05
Inactivation Date2019-11-13

NDC 45865-364-15 [45865036415]

Diclofenac Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05
Inactivation Date2019-11-13

NDC 45865-364-90 [45865036490]

Diclofenac Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM100 mg/1

OpenFDA Data

SPL SET ID:d349b4ca-3aec-44a8-a4d5-87be4c822190
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855657

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Decreased Prostaglandin Production [PE]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Diclofenac Sodium Extended-Release" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    21695-040Diclofenac Sodium Extended-ReleaseDiclofenac Sodium Extended-Release
    45865-364Diclofenac Sodium Extended-ReleaseDiclofenac Sodium Extended-Release
    0280-0039Aleve Arthritis Pain GelDiclofenac Sodium
    0115-1483Diclofenac SodiumDiclofenac Sodium
    0168-0803DICLOFENAC SODIUMdiclofenac sodium
    0168-0844DICLOFENAC SODIUMdiclofenac sodium
    0228-2550Diclofenac SodiumDiclofenac Sodium
    0228-2551Diclofenac SodiumDiclofenac Sodium
    0363-1210Diclofenac sodiumDiclofenac sodium
    0363-1871diclofenac sodiumdiclofenac sodium
    0378-0355Diclofenac SodiumDiclofenac Sodium
    0378-6280Diclofenac Sodiumdiclofenac sodium
    0378-6281Diclofenac Sodiumdiclofenac sodium
    0113-1189good sense arthritis paindiclofenac sodium
    0067-8152Voltarendiclofenac sodium
    0067-8153Voltarendiclofenac sodium
    0078-0478VOLTARENdiclofenac sodium
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